TY - JOUR
T1 - Drug patent live and generic competition
T2 - Analysis of new molecular entities approved by the FDA between 1980 and 1999
AU - Seoane-Vazquez, Enrique C.
AU - Schondelmeyer, Stephen W.
AU - Szeinbach, Sheryl L.
N1 - Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2008/6/20
Y1 - 2008/6/20
N2 - This study estimates the patent life of new molecular entities (NMEs) approved by the U.S. Food Drug Administration (FDA) in the period 1980-1999 and analyzes the relationship between generic competition and patents listed in the FDA's Orange Book. A model was developed to describe and analyze the NME's patent life. A total of 340 NMEs were included in the analysis. The results of the study demonstrate an increase in post-new drug application patent time in the 1990s. Several factors explain this increase including reduction of the new drug application review time, pharmaceutical patent extensions, pediatric exclusivity, and changes in patent statutory term.
AB - This study estimates the patent life of new molecular entities (NMEs) approved by the U.S. Food Drug Administration (FDA) in the period 1980-1999 and analyzes the relationship between generic competition and patents listed in the FDA's Orange Book. A model was developed to describe and analyze the NME's patent life. A total of 340 NMEs were included in the analysis. The results of the study demonstrate an increase in post-new drug application patent time in the 1990s. Several factors explain this increase including reduction of the new drug application review time, pharmaceutical patent extensions, pediatric exclusivity, and changes in patent statutory term.
KW - Drug exclusivity
KW - Drug patents
KW - New molecular entities
UR - http://www.scopus.com/inward/record.url?scp=66249084667&partnerID=8YFLogxK
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U2 - 10.1080/15385690801963530
DO - 10.1080/15385690801963530
M3 - Article
AN - SCOPUS:66249084667
SN - 1538-5698
VL - 16
SP - 67
EP - 85
JO - Journal of Pharmaceutical Finance, Economics and Policy
JF - Journal of Pharmaceutical Finance, Economics and Policy
IS - 4
ER -